For MEM-MD-68, the primary efficacy parameter—proportion of participants with LTR on the SRS by study end—was analyzed using the Cochran–Mantel–Haenszel test, controlling for ASD subtype. A total of 81 (10.8%) completed the study by the time of early termination (31 January 2014; see Studies and procedures). In the reduced-dose arm, the weight-based memantine dose received in MEM-MD-91 was reduced by ⩾50%. If the address matches an existing account you will receive an email with instructions to reset your password Keep a list of your medicines with you to show your doctor and pharmacist. Supplemental materialSupplemental material for this article is available online. The median time to first LTR was 29 days (95% CI: 28, 42) for the placebo group, and 30 days (95% CI: 28, 44) and 33 days (95% CI: 28, 56) for the memantine full-dose and reduced-dose groups, respectively. Adderall in a safe place to prevent misuse and abuse. B., Davenport, T. A., Guastella, A. J. Although this scenario is probably unlikely, limiting the use of concomitant medications should be considered when designing future ASD clinical trials. Adderall may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. If you have ADHD, you need to try this. This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). If you have specific questions regarding a drug’s safety, side effects, usage, warnings, etc., you should contact your doctor or pharmacist, or refer to the individual drug monograph details found on the FDA.gov or RxList.com websites for more information. In one recent randomized, double-blind, placebo-controlled study published by Ghaleiha et al. The percentage of participants achieving ⩾10-point improvement in SRS total raw scores was comparable regardless of intervention (Figure 7), and ~90% of participants overall demonstrated improvement (Figure 7 inset). The study sponsor (Forest Research Institute (FRI), Jersey City, NJ; currently Allergan plc) made an administrative decision to terminate MEM-MD-69 prematurely based on results from the previously initiated double-blind controlled studies MEM-MD-57A and MEM-MD-68. Each study was conducted in full compliance with FDA guidelines for good clinical practice and in accordance with the ethical principles of the Declaration of Helsinki and the Code of Federal Regulations (CFR) (21CFR312.120). Most TEAEs were mild to moderate in intensity. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP … Although the maximal weight-based dose groups were identified in Part 1 of the MEM-MD-57A trial (N = 12), a previous pilot study of memantine found that memantine doses 10–20  mg/day were well tolerated in pediatric ADHD participants with the 20 mg/day dose conferring greater improvement on efficacy measures than the 10 mg/day dose (Findling et al., 2007). Cumulative percentages of patients achieving a given change from baseline in SRS total raw score (Double-blind, Placebo-controlled trial MEM-MD-68). (, Carrothers, T. J., Periclou, A., Khariton, T., Ghahramani, P. (, Chez, M. G., Burton, Q., Dowling, T., Chang, M., Khanna, P., Kramer, C. (, Choudhury, P. R., Lahiri, S., Rajamma, U. One of the memantine benefits is for ADHD patients. Adderall may affect your or your child's ability to drive or do other dangerous activities. the site you are agreeing to our use of cookies. The abbreviated term ADHD denotes the condition commonly known as: 6 Parenting Tips for Raising Kids With ADHD. Keep Based on the SRS manual, the SD of parent report for the entire standardization sample (N = 1011) was 24.6 with a mean of 31.2 and an SEM of 6.29. All drug information provided on RxList.com is sourced directly from drug monographs published by the U.S. Food and Drug Administration (FDA). In PDD-NOS participants, the proportions of participants experiencing LTR were comparable between dose groups (Table 2). The baseline for each MEM-MD-69 efficacy parameter was baseline of the first lead-in study. Adderall is also used in the treatment of a sleep disorder called narcolepsy. Furthermore, the nocebo effect—that individuals may have perceived a loss of efficacy in the double-blind study and thus assumed they were receiving placebo, leading to further losses of therapeutic benefit—may have occurred. This sample size was considered convincingly large to detect a clinically meaningful difference in LTR, as agreed upon with the FDA (8 May 2013). For more information view the SAGE Journals Sharing page. Of 479 (92.6%) confirmed responders from lead-in study MEM-MD-91 who were randomized, 477 received ⩾1 dose of double-blind study medication, and 471 participants had ⩾1 post-baseline SRS total raw score assessment and were included in the ITT population (Figure 2). It comes in three forms: immediate-release tablet, oral solution, and extended-release capsule. Approximately 75% of all participants achieved ⩾10-point improvement in SRS total raw score (Figure 4(a)). The study aims to examine the effects of treatment with memantine on ADHD symptoms. The SRS has been used as a primary measure of response to intervention in several other clinical trials (Aman et al., 2016; Constantino et al., 2003; Parker et al., 2017; Yatawara, Einfeld, Hickie, Davenport, & Guastella, 2016). Chronic and episodic use of analgesics (nonnarcotic only), antiacne medications (topical only, excluding isotretinoin), antihistamines, topical antifungal agents, anti-inflammatory drugs (excepting indomethacin and systemic corticosteroids), antipsoriatic treatments (except acitretin), anxiolytics, H2 blockers/proton pump inhibitors (only if stable for at least 6 months prior to lead-in study), laxatives (if taken before lead-in study), migraine treatment, muscle relaxants, sedatives/hypnotics, steroids (topical, inhalant, intranasal), vitamins, and herbal remedies was allowed. Talk to your doctor if you or your child have side effects that are bothersome or do not go away. Researchers considered memantine as a possible autism treatment because it lowers the activity of so-called NMDA receptors. This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with OROS-Methylphenidate (OROS-MPH, Concerta). Table 3. In MEM-MD-68, there was no difference between memantine and placebo on the primary efficacy parameter, the proportion of patients with a loss of therapeutic response (defined as ⩾10-point increase from baseline in Social Responsiveness Scale total raw score). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Among participants in the initial open-label study, there was a considerable decrease in mean SRS scores from baseline, a change that was presumed to be a clinically important improvement. P2 is the P value for the treatment comparison between memantine reduced-dose and placebo based on log-rank test stratified by Autism Spectrum Disorder subtype. Cumulative percentage of patients achieving a 10-point minimum improvement in SRS total raw score from baseline among a) all patients, and b) confirmed responders (Open-label Trial MEM-MD-91). Especially tell your doctor if you or your child take: Know the medicines that you or your child take. Overall, 30.1% completed the study and 65.8% discontinued due to LTR (Supplemental Material 2). In a 12-week, randomized, double-blind, placebo-controlled trial (MEM-MD-57A, NCT00872898; conducted May 2009 through August 2012) in which memantine-ER was administered over a limited, weight-based dose range (3–15 mg/day), there was a trend toward improvement on the primary efficacy measure of caregiver/parent ratings on the Social Responsiveness Scale (SRS) of ~10 points from baseline in both treatment groups, but no significant between-group differences were observed between memantine-ER and placebo at study end (Aman et al., 2016). Briefly, open-label memantine-ER was administered by weight in trials MEM-MED-91 and MEM-MD-69, and participants were divided into four weight groups: group A, ⩾60 kg; group B, 40–59 kg; group C, 20–39 kg; and group D, <20 kg. Findings from these three studies of memantine-ER in ASD participants are reported here. Memantine and ADHD. Mean (standard deviation (SD)) treatment duration was similar between weight-based treatment groups (Table 2) and slightly shorter among those with autistic disorder (92.3 (38.6) days) versus either Asperger’s disorder (98.8 (45.4) days), or PDD-NOS (99.5 (45.3) days). Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist used to treat moderate to severe Alzheimer's type dementia. In open-label trial MEM-MD-91, a total of 1262 children were screened, 906 enrolled, and 903 received ⩾1 weight-based open-label memantine-ER dose. Adderall is a central nervous system stimulant prescription medicine. If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Many people using Namenda do not have serious side effects. Figure 7. Participants who completed MEM-MD-68 or who discontinued due to loss of therapeutic response (LTR)—defined as a ⩾10-point increase in SRS total raw score at any double-blind visit versus SRS score at randomization—were eligible to enroll into the long-term open-label safety study, MEM-MD-69. namenda. ... And the rest of the link gives good advice on working with a child who has ADHD and is lying. Extended-release (ER) memantine monotherapy was investigated in children with autistic disorder, Asperger’s disorder, or PDD-NOS as part of a phase 2 clinical development program designated under the US FDA Pediatric Written Request (PWR). the last available measurement before the first dose of study medication). SRS total raw scores were numerically greater among those with Asperger’s disorder versus either autistic disorder or PDD-NOS (Supplemental Material 1). Treatment with immediate-release (IR) memantine—a low-to-moderate affinity, uncompetitive NMDA receptor antagonist—has been shown to improve both communication and social interactions in several trials conducted in individuals with ASD and pervasive developmental disorder not-otherwise specified (PDD-NOS) (Chez et al., 2007; Ghaleiha et al., 2013; Owley et al., 2006). METHOD: This was a 12-week, double-blind, placebo-controlled, randomized clinical trial of memantine added to open-label treatment with stimulant medication. A total of 160 participants were randomized to placebo, 158 to their full memantine dose received during MEM-MD-91 and 161 to a reduced memantine dose (at least 50% reduction). Three participants discontinued; of the three that continued, memantine was reduced only in the participant who experienced gastroenteritis. Due to the time-sensitive nature of drug information, RxList.com makes no guarantees that the information provided is the most current. Adderall should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Thus, the LTR criterion used in these trials may simply not have been an appropriate measure in this patient population known to have a high placebo response rate. Adderall tablets are usually taken two to three times a day. The most common TEAEs were irritability, vomiting, agitation, and anxiety (Table 3). A numerically greater proportion of placebo-treated participants with autistic disorder experienced LTR (73.0%) versus full-dose (64.3%) and reduced dose (66.7%), indicating a trend in favor of memantine ER for this ASD subtype. Adderall may harm others, and is against the law. Both Namenda and Adderall may interact with sodium bicarbonate (Alka-Seltzer) or diuretics (water pills). I also read that memantine by itself has bettering benefits for ADHD and at this point, anything that helps with ADHD might be worth a try. As pediatric patients are expected to gain weight during the course of development, study participants could be reassigned to the next higher weight group during the course of the study (per prespecified criteria) to maintain drug exposure levels that were considered therapeutically equivalent if a participant’s weight deviated significantly over time. Memantine + Methylphenidate for ADHD - will memory issues go away with time? Mean SRS total raw score at visit 1 (extension baseline) was 86.7 ± 29.5 (safety population), which was approximately 21 points lower than baseline of the lead-in study (108.4 ± 24.5). Still, Lipton saw NMDA receptors as a good target for treating autism … MEM-MD-91, a 50-week open-label trial, identified memantine extended-release treatment responders for enrollment into MEM-MD-68, a 12-week randomized, double-blind, placebo-controlled withdrawal trial. The percentage of confirmed responders was similar between autistic disorder (57.4%) and Asperger’s disorder (60.9 %) and numerically greater in PDD-NOS (66.7%). In the double-blind study (MEM-MD-68), participants were randomized 1:1:1 to memantine-ER full-dose, memantine-ER reduced dose (to assess dose response per FDA request), or placebo. Having spent almost 40 years in the classroom. Namenda is used off-label for ADHD. Baseline demographics were generally comparable across ASD subtypes (Supplemental Material 1), and 83.8% of participants were taking concomitant medications and supplements, most commonly (⩾10.0%) melatonin (17.0%), multivitamin (15.9%), ibuprofen (11.4%), risperidone (10.6%), and paracetamol (10.3%). Compared with baseline, fewer participants had an overall CGI-S rating of severely ill (1.3% vs 7.8%), markedly ill (9.4% vs 32.0%), or moderately ill (37.9% vs 48.1%) at study end. Table 1. At week 9 (first post-baseline SRS assessment), 543 (62.6%) responded to treatment and 517 (59.6%) were confirmed SRS responders. The molecular mechanisms of ASD are not fully understood but may involve altered glutamatergic signaling. Mean (SD) changes from baseline at week 12 in SRS total raw scores ranged from −8.0 (10.0) in the placebo-treated Asperger’s group to −25.7 (18.4) in the full-dose Asperger’s group (Table 2). The most commonly reported TEAEs (> 5.0%) were nasopharyngitis, vomiting, pyrexia, and headache (Table 3). This randomized-withdrawal study was designed per FDA Guidance for Industry E11 Clinical Investigation of Medicinal Products in the Pediatric Population. AEs leading to premature discontinuation occurred in 60 (6.6%) participants, with a slightly higher percentage among those with autistic disorder (7.8%) than with Asperger’s disorder (4.4%) or PDD-NOS (4.4%). This suggests that the memantine doses used in these ASD studies were possibly inadequate for most trial participants, despite results from a population pharmacokinetic study that suggested the appropriateness of the weight-based memantine ER dosing (Carrothers, Periclou, Khariton, & Ghahramani, 2014). One participant in the placebo group (Asperger’s disorder) discontinued the study due to an AE (irritability), and one participant in the reduced-memantine group reported an on-therapy SAE (furuncle of the nasal bridge) that was unrelated to study drug. So it certainly is not guaranteed. The ABC-C is a 58-item questionnaire with five subsections to assess behavioral symptoms of irritability, social withdrawal, stereotypy, hyperactivity/noncompliance, and inappropriate/repetitive speech. Figure 5. Do not start any new medicine while taking Adderall without talking to your doctor first. In MEM-MD-91, 517 (59.6%) participants were confirmed Social Responsiveness Scale responders at week 12; mean Social Responsiveness Scale total raw scores improved two to three times a minimal clinically important difference of 10 points. If memantine was effective for a subgroup of participants (even though the characteristics of those individuals may not yet be known), these trial results may support the notion that altered glutamatergic signaling is at least partly underlying the poorly understood molecular mechanisms of ASD; perhaps greater success could have been achieved with a higher, flexible-dose range. FundingThe author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Funding for these studies was provided by Forest Research Institute (Jersey City, NJ), the sponsor at the time the studies were conducted. Any time, RxList.com makes every effort to update its drug information is! 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