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DyskinesiaPhase 3NCT02202551

Open-Label Safety Study of ADS-5102 in PD Patients With LID

A Phase 3 study testing ADS-5102 in people with Dyskinesia and Levodopa Induced Dyskinesia (LID), run by Adamas Pharmaceuticals, Inc. at 87 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID). Read more about this study

Who is it for?
Ages 30 to 85 years
What is being tested?
ADS-5102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
223 participants
Where
87 sitesin 6 countries
Study dates
Jul 2014to Feb 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed a current IRB/REB/IEC-approved informed consent form
  • Completed all study visits in previous Adamas efficacy study or were ineligible for participation in previous Adamas studies due to having undergone prior deep brain stimulation.
  • Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
  • On a stable regimen of antiparkinson's medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily.
  • History of peak dose dyskinesia that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator

Who cannot join

  • Discontinued ADS-5102 in previous Adamas efficacy study due to intolerable or unacceptable AEs considered to be related to ADS-5102
  • History of neurosurgical intervention related to Parkinson's disease, with the exception of deep brain stimulation
  • History of seizures since completion of participation in previous Adamas studies or within 2 years
  • History of stroke or TIA since completion of participation in previous Adamas studies or within 2 years
  • History of cancer since completion of participation in previous Adamas studies or within 2 years, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
  • Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening
Show all 11Show fewer
  • If female is pregnant or lactating
  • If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment.
  • Treatment with an investigational drug (other than ADS-5102) or device within 30 days prior to screening
  • Treatment with an investigational biologic within 6 months prior to screening
  • Current or planned participation in another interventional clinical trial

Trial locations and contacts

87 sites in 6 countries.

87 sites in 6 countries

United States54 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Atlanta, Georgia, 30329

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bingham Farms, Michigan, 48025

  • Study site

    Birmingham, Alabama, 35233

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Commack, New York, 11725

  • Study site

    Dallas, Texas, 75390

  • Study site

    Des Moines, Iowa, 45219

  • Study site

    Elkridge, Maryland, 21075

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Golden Valley, Minnesota, 55427

  • Study site

    Greensboro, North Carolina, 27405

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Houston, Texas, 77030-1

  • Study site

    Houston, Texas, 77030-2

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kirkland, Washington, 98034

  • Study site

    Manchester, Connecticut, 06040

  • Study site

    Milwaukee, Wisconsin, 53233

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    Naples, Florida, 34102

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10029

  • Study site

    Pasadena, California, 91105

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Port Charlotte, Florida, 33980

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Reseda, California, 91335

  • Study site

    Roanoke, Virginia, 24018

  • Study site

    Sacramento, California, 95817

  • Study site

    Scottsdale, Arizona, 85259

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Sun City, Arizona, 85351

  • Study site

    Sunnyvale, California, 94085

  • Study site

    Sunrise, Florida, 33351

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tampa, Florida, 33613

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Torrance, California, 90505

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Ventura, California, 93003

  • Study site

    West Bloomfield, Michigan, 48322

  • Study site

    Weston, Florida, 33331

Other trials in United States

Germany12 sites

  • Study site

    Beelitz-Heilstätten, Brandenburg, 14547

  • Study site

    Berlin, 12163

  • Study site

    Berlin, 13353

  • Study site

    Gera, Thuringia, 07751

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Hamburg, 22291

  • Study site

    Kassel, 34128

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Marburg, 35043

  • Study site

    München, Bavaria, 80804

  • Study site

    München, Bavaria, 81675

  • Study site

    Stadtroda, Thuringia, 07646

Other trials in Germany

France11 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Bron, 69677

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Lille, 59037

  • Study site

    Marseille, 13385

  • Study site

    Montpellier, 34295

  • Study site

    Poitiers, 86021

  • Study site

    Rennes, 35033

  • Study site

    Rouen, 76031

  • Study site

    Strasbourg, 67098

  • Study site

    Toulouse, 31059

Other trials in France

Spain4 sites

  • Study site

    Barcelona, 08028

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08041

Other trials in Spain

Austria3 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Vienna, 1080

  • Study site

    Vienna, 1220

Other trials in Austria

Canada3 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Regina, Saskatchewan, S4T 1A5

  • Study site

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)

This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).

Read the detailed description

Participation in this study was offered to subjects who were described by one of the following 3 groups:

  • Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and chose to immediately transition into the current study without a time gap; this group was subdivided into Group 1A, consisting of subjects who received ADS-5102 in the previous Adamas efficacy study, and Group 1P, consisting of subjects who received placebo in the previous Adamas efficacy study
  • Group 2: Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in LID and entered the current study with a time gap
  • Group 3: Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS

Consented subjects who completed Screening (Visit 1) and met study eligibility criteria were to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2 capsules) daily at bedtime; this dose was to continue through Week 100. During the final week (Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1 capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to complete the 1 week of reduced dosing.

Efficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up Visit was to occur approximately 2 weeks following the completion of treatment. AEs were recorded beginning with the first dose of study drug and continued through the Safety Follow-up Visit. Concomitant medications were recorded throughout the study.

Being tested
ADS-5102
Keywords
Levodopa Induced Dyskinesia, LID, Parkinsonism, Parkinson's Disease
Medical subject headings
Dyskinesias, Parkinson Disease, Parkinsonian Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADS-5102Drug

    Also called amantadine HCl extended release

Study groups in NCT02202551
Study groupRoleWhat they receive
ADS-5102Experimentalamantadine HCl extended release
Receives: Drug: ADS-5102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations

    The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).

    Measured: Up to 101 weeks

Secondary outcomes (2)

  1. Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)

    To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III.

    Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4).

    Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better.

    Parts I, II, and III are summed to make the total score.

    Measured: Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).

  2. Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)

    This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score.

    Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24

    Measured: 100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02202551
Sponsor's protocol ID
ADS-AMT-PD302
Status last verified
Aug 2020
First submitted
25 Jul 2014
Last updated
6 Oct 2020
Data monitoring committee
No

Publications

  • Aoki FY, Sitar DS. Clinical pharmacokinetics of amantadine hydrochloride. Clin Pharmacokinet. 1988 Jan;14(1):35-51. doi: 10.2165/00003088-198814010-00003.

    PubMed 3280212

  • Colosimo C, Martinez-Martin P, Fabbrini G, Hauser RA, Merello M, Miyasaki J, Poewe W, Sampaio C, Rascol O, Stebbins GT, Schrag A, Goetz CG. Task force report on scales to assess dyskinesia in Parkinson's disease: critique and recommendations. Mov Disord. 2010 Jul 15;25(9):1131-42. doi: 10.1002/mds.23072.

    PubMed 20310033

  • da Silva-Junior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. doi: 10.1016/j.parkreldis.2005.05.008. Epub 2005 Sep 9.

    PubMed 16154788

  • Dallos V, Heathfield K, Stone P, Allen FA. Use of amantadine in Parkinson's disease. Results of a double-blind trial. Br Med J. 1970 Oct 3;4(5726):24-6. doi: 10.1136/bmj.4.5726.24.

    PubMed 4919119

  • Del Sorbo F, Albanese A. Levodopa-induced dyskinesias and their management. J Neurol. 2008 Aug;255 Suppl 4:32-41. doi: 10.1007/s00415-008-4006-5.

    PubMed 18821084

  • Encarnacion EV, Hauser RA. Levodopa-induced dyskinesias in Parkinson's disease: etiology, impact on quality of life, and treatments. Eur Neurol. 2008;60(2):57-66. doi: 10.1159/000131893. Epub 2008 May 15.

    PubMed 18480609

  • Factor SA, Molho ES. Transient benefit of amantadine in Parkinson's disease: the facts about the myth. Mov Disord. 1999 May;14(3):515-7. doi: 10.1002/1531-8257(199905)14:33.0.co;2-z. No abstract available.

    PubMed 10348482

  • Goetz CG, Nutt JG, Stebbins GT. The Unified Dyskinesia Rating Scale: presentation and clinimetric profile. Mov Disord. 2008 Dec 15;23(16):2398-403. doi: 10.1002/mds.22341.

    PubMed 19025759

  • Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

    PubMed 19025984

  • Goetz CG, Stebbins GT, Chung KA, Hauser RA, Miyasaki JM, Nicholas AP, Poewe W, Seppi K, Rascol O, Stacy MA, Nutt JG, Tanner CM, Urkowitz A, Jaglin JA, Ge S. Which dyskinesia scale best detects treatment response? Mov Disord. 2013 Mar;28(3):341-6. doi: 10.1002/mds.25321. Epub 2013 Feb 6.

    PubMed 23390076

  • Hayden FG, Gwaltney JM Jr, Van de Castle RL, Adams KF, Giordani B. Comparative toxicity of amantadine hydrochloride and rimantadine hydrochloride in healthy adults. Antimicrob Agents Chemother. 1981 Feb;19(2):226-33. doi: 10.1128/AAC.19.2.226.

    PubMed 7347558

  • Jackson G, Stanley E, Lee Muldoon R. Chemoprophylaxis of viral respiratory diseases. Bulletin Pan Am Health Org. 1967; 147: 595-603.

  • Luginger E, Wenning GK, Bosch S, Poewe W. Beneficial effects of amantadine on L-dopa-induced dyskinesias in Parkinson's disease. Mov Disord. 2000 Sep;15(5):873-8. doi: 10.1002/1531-8257(200009)15:53.0.co;2-i.

    PubMed 11009193

  • Ory-Magne F, Corvol JC, Azulay JP, Bonnet AM, Brefel-Courbon C, Damier P, Dellapina E, Destee A, Durif F, Galitzky M, Lebouvier T, Meissner W, Thalamas C, Tison F, Salis A, Sommet A, Viallet F, Vidailhet M, Rascol O; NS-Park CIC Network. Withdrawing amantadine in dyskinetic patients with Parkinson disease: the AMANDYSK trial. Neurology. 2014 Jan 28;82(4):300-7. doi: 10.1212/WNL.0000000000000050. Epub 2013 Dec 26.

    PubMed 24371304

  • Paci C, Thomas A, Onofrj M. Amantadine for dyskinesia in patients affected by severe Parkinson's disease. Neurol Sci. 2001 Feb;22(1):75-6. doi: 10.1007/s100720170054.

    PubMed 11487209

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ADS-5102 in people with Dyskinesia and Levodopa Induced Dyskinesia (LID), run by Adamas Pharmaceuticals, Inc. at 87 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Germany, France, Spain, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations (time frame: Up to 101 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02202551, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.

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