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Huntington's DiseasePhase 3MermaiHDNCT00665223

A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease

A Phase 3 study testing ACR16 in people with Huntington's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 31 sites in 8 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

The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Huntington's Disease
What is being tested?
ACR16
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
437 participants
Where
31 sitesin 8 countries
Study dates
24 Apr 2008to 14 Jun 2010
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written Informed Consent prior to any study related procedure.
  • Huntington's disease diagnosed with the aid of clinical features and a positive family history and/or the presence of ≥ 36 CAG repeats in the Huntington gene.
  • Male or female age ≥ 30 years.
  • Willing and able to take oral medication and able to comply with the study specific procedures.
  • Ambulatory, being able to travel to the assessment centre, and judged by the Investigator as likely to be able to continue to travel for the duration of the study.
  • Availability of a caregiver or family member to accompany the participant.
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  • A sum of ≥ 10 points on the mMS at the screening visit.
  • For participants taking allowed antipsychotic medication, the dosing of medication must have been kept constant for at least 6 weeks before randomization. The allowed antipsychotic medication is Amisulpride, Haloperidol, Olanzapine, Risperidone, Sulpiride, or Tiapride.
  • For participants taking allowed antidepressant or other psychotropic medication, the dosing of medication must have been kept constant for at least 6 weeks before randomization.
  • Willing to provide a blood sample for CAG analysis (where CAG result is not already available).
  • In France only, the participant must be affiliated to a social security system or be a beneficiary of such a system.

Who cannot join

  • Unable to give written informed consent.
  • Treatment with any non-allowed antipsychotic medication within 12 weeks of randomization. The non-allowed antipsychotic medication is any medication other than Amisulpride, Haloperidol, Olanzapine, Risperidone, Sulpiride, or Tiapride.
  • Treatment with the antidepressants Fluoxetine or Paroxetine within 6 weeks of randomization.
  • Use of Tetrabenazine within 12 weeks of randomization, or at any time during the study period.
  • Treatment with any investigational product within 4 weeks of randomization.
  • Use of tricyclic antidepressants, class I antiarrhythmics, and strong CYP2D6 inhibitors such as Ajmalicine, Chinidin/Quinidine and Ritonavir, within 6 weeks of randomization.
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  • Participants previously included into this study.
  • A prolonged QTc interval at screen (defined as a QTc interval of > 450 milliseconds [msec] for males or > 470 msec for females), or other clinically significant heart conditions.
  • Creatinine clearance <40 milliliters (mL)/minute (min) as measured at the screening visit.
  • Any clinically significant, abnormal, baseline laboratory result which in the opinion of the Investigator, affects the participants' suitability for the study or puts the participant at risk if he/she enters the study.
  • Clinically significant hepatic or renal impairment.
  • Participants with a history of epilepsy or a history of seizure(s) of unknown cause.
  • Severe intercurrent illness, which, in the opinion of the Investigator, may put the participant at risk when participating in the trial or may influence the results of the trial or affect the participants' ability to take part in the trial.
  • Alcohol and/or drug abuse as defined by Diagnostic and Statistical Manual - Fourth Edition - Text Revision (DSM IV-TR) criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months.
  • Participants with suicidal ideation, defined as a positive score on criteria for major depressive episode, item A9 on the DSM-IV-TR criteria for a Major Depressive Episode.
  • Females who are pregnant or lactating.
  • Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
  • Known allergy to any ingredients of the trial medication or placebo.
  • Any previous participation in a clinical study with ACR16.
  • Participants currently receiving deep brain stimulation.
  • Participants with a history of surgical procedures aiming to improve the symptoms of Huntington's disease, such as neural transplantations, lesions of the central nervous system, infusions of neurotrophic agents or previous attempts of deep brain stimulation.

Trial locations and contacts

31 sites in 8 countries.

31 sites in 8 countries

United Kingdom9 sites

  • First Floor Argyll House, Fosterhill, Cornhill Road

    Aberdeen, Scotland, AB25 2ZR

  • R&D Headquarters, Barberry Centre, 25 Vincent Drive

    Birmingham, England/West Midlands, B15 2SG

  • Cambridge Centre for Brain repair, Cambridge University

    Cambridge, CB2 2PY

  • Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park

    Cardiff, Wales, CF14 4XN

  • SE Scotland Genetic Service, Western General Hospital, Crewe Road

    Edinburgh, Scotland, EH4 2XU

  • Department of Clinical Genetics, St Mary's Hospital, Hathersage Road

    Manchester, North West England, M13 9WL

  • Institute of Human Genetics, Centre for Life, Central Parkway

    Newcastle upon Tyne, Tyne and Wear, NE1 3BZ

  • Churchill Hospital, Old Road, Headington

    Oxford, South East England, OX3 7LJ

  • Academic Neurology Unit, E Floor Medical School Beech Hill Road

    Sheffield, South Yorkshire, S10 2RX

Other trials in United Kingdom

Germany7 sites

  • Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Schumannstrasse 20/21

    Berlin, 10117

  • St. Josef Hospital, Ruhr University Bochum, Gudrunstraße 56

    Bochum, North Rhine-Westphalia, 44791

  • Universitat Dresden, Klinikum Carl Gustav Carus, Fetscherstr. 74

    Dresden, Saxony, 01307

  • Klinikum rechts der Isar der Technischen Universität München, Neurologische Klinik und Poliklinik, Ismaninger Str. 22

    München, Bavaria, 81675

  • Westfaelische Wilhelms-Universitaet Muenster, Klinik fur Neurologie

    Münster, North Rhine-Westphalia, 48149

  • Isar Amper Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils), Bräuhausstr.5

    Taufkirchen (Vils), Bavaria, 84416

  • Universitätsklinik Ulm, Neurologie/ Oberer Eselberg 45/1

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

France4 sites

  • Hôpital Nord, CHU d'Amiens, Service de Neurologie

    Amiens, Picardie, 80054

  • CHU Roger Salengro

    Lille, Hauts-de-France, 59037

  • CHU La Timone, 264 Rue Saint Pierre

    Marseille, Provence-Alpes-Côte d'Azur Region, 13385

  • Hôpital Purpan, Place Docteur-Baylac, Bâtiment F

    Toulouse, Midi-Pyrénées Region, 31059

Other trials in France

Spain4 sites

  • Hospital Clinic of Barcelona, Calle Villarroel, 170

    Barcelona, 08036

  • Hospital Ramon y Cajal, Carretera Colemenar km 9.100

    Madrid, 28034

  • Hospital Mútua de Terrassa, C/ Castell

    Terrassa, Catalonia, 08225

  • Hospital Universitario La Fe, Avda. Campanar 21,

    Valencia, 46009

Other trials in Spain

Austria2 sites

  • LKH -Univ. Klinikum Graz, Universitaetsklinik fur Psychiatrie Graz

    Graz, Styria, 8036

  • Innsbruck Medical University, Anichstraße 35

    Innsbruck, Tyrol, A-6020

Other trials in Austria

Italy2 sites

  • Fondazione IRCCS Istituto Nazionale Neurologico "Carlos Besta", Department of Movement Disorders, 11 via Celoria

    Milan, Lombardy, 20133

  • IRCCS Neuromed, Localita Camarelle

    Pozzilli, Molise, 86077

Other trials in Italy

Portugal2 sites

  • University Hospital of Coimbra, Av. Rissaya Barreto

    Coimbra, Baixo Mondego, 3000-075

  • Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz

    Lisbon, 1649-028

Other trials in Portugal

Belgium1 site

  • University Hospital Gasthuisberg

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

About this study

Official title: A Multicentre, Multinational, Randomised, Double-Blind, Parallel-Group Study Comparing ACR16 45 mg Once-Daily or Twice-Daily Versus Placebo for the Symptomatic Treatment of Huntington's Disease

The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease.

Read the detailed description

The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in Huntington's disease based on the Unified Huntington"s Disease Rating Scale (UHDRS) subscale. These symptoms seem to be most important for the functional disability associated with the disorder. To achieve this, participants are randomized to ACR16 45 mg once daily, ACR16 45 mg twice daily, or placebo treatment in equal proportions in a parallel design for a treatment duration of 26 weeks.

Being tested
ACR16, Placebo
Keywords
Huntington's Disease
Medical subject headings
Huntington Disease

What participants receive

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

  • ACR16Drug

    Also called Pridopidine

    Capsules will be swallowed whole with water.

  • PlaceboDrug

    Capsules will be swallowed whole with water.

Study groups in NCT00665223
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive a placebo capsule matching to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule will be taken twice daily as 2 separate doses.
Receives: Drug: Placebo
ACR16 45 mgExperimentalParticipants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule will be taken as 2 separate doses.
Receives: Drug: ACR16; Drug: Placebo
ACR16 90 mgExperimentalParticipants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule will be taken twice daily as 2 separate doses (total dose: 90 mg)
Receives: Drug: ACR16

What is being measured

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

  1. Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the Unified Huntington's Disease Rating Scale [UHDRS] Motor Assessments) at Week 26

    The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS include dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items are rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranges from 0 to 52, with higher scores indicating more severe motor impairment.

    Measured: Baseline, Week 26

Secondary outcomes (7)

  1. The UHDRS Functional Assessment at Week 26

    The UHDRS Functional Assessment considers 25 items associated with functional problems. The participant scores 1 point for every item to which they respond positively (zero points for negative responses). Total score ranges from 0 (worst) to 25 (best). Higher scores indicate better functional ability.

    Measured: Week 26

  2. Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score

    Global improvement is rated by the investigator on a 7-point scale as: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse.

    Measured: Week 26

  3. Change From Baseline in Stroop Word Reading Test at Week 26

    The Stroop test measures the ability to concentrate and ward off distractions. The test consists of three items: (i) colour naming; (ii) word reading; (iii) interference. The word reading test requires participants to read colour words written in black and each response is scored as the number of correct answers made in 45 seconds. Higher scores indicate less severe disease, and an increase in score represents an improvement.

    Measured: Baseline, Week 26

  4. Change From Baseline in Total UHDRS Behavioral Assessment Score at Week 26

    The total behavioral assessment score is the sum of the 11 products (depressed mood, apathy, low self-esteem/guilt, compulsive behavior, anxiety, irritable behavior, perseverative/obsessive thinking, disruptive/aggressive behavior, suicidal thoughts, delusions, and hallucinations) of frequency and severity symptom scores and excluded the 3 yes/no questions relating to confusion, dementia, and depression. Frequency is rated on a scale of 0 (never or almost never) to 4 (very frequently, most of the time). Severity is rated on a scale of 0 (no evidence) to 4 (severe). Total behavior score ranges from 0 (no impairment) to 88 (severe impairment), with higher scores indicating greater behavioral impairments.

    Measured: Baseline, Week 26

  5. Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score at Week 26

    HADS is a self-administered instrument reliable for detecting states of depression and anxiety. It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale is comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale where higher scores indicate greater severity of anxiety and depression symptoms. The total HADS score was a composite score summed of all 14 items for a total range of 0 to 42. Lower change from baseline scores indicate improvement.

    Measured: Baseline, Week 26

  6. Randomized Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was defined as any change from the participant's baseline (pre-treatment) condition, other than improvement, that did not necessarily have causal relationship with the study drug. TEAEs were defined as AEs that began after ACR16/placebo administration through week 26 or up to week 30 for participants not continuing in the open-label period. AEs included both serious adverse events (SAEs) and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

    Measured: Baseline up to Week 30

  7. Open-label Phase: Number of Participants With TEAEs

    An AE was defined as any change from the participant's baseline (pre-treatment) condition, other than improvement, that did not necessarily have causal relationship with the study drug. TEAEs were defined as adverse events that began after ACR16/placebo administration through Week 56. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

    Measured: Week 26 up to Week 56

Timeline

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

  1. First posted23 Apr 2008 (estimated)
  2. Study start24 Apr 2008
  3. Primary completion14 Jun 2010
  4. Study completion14 Jun 2010

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00665223
Sponsor's protocol ID
ACR16 C008
Acronym
MermaiHD
Status last verified
Jul 2023
First submitted
22 Apr 2008
Last updated
29 Aug 2023
Data monitoring committee
Yes

Publications

  • Darpo B, Geva M, Ferber G, Goldberg YP, Cruz-Herranz A, Mehra M, Kovacs R, Hayden MR. Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose. Neurol Ther. 2023 Apr;12(2):597-617. doi: 10.1007/s40120-023-00449-w. Epub 2023 Feb 22.

    PubMed 36811812

  • de Yebenes JG, Landwehrmeyer B, Squitieri F, Reilmann R, Rosser A, Barker RA, Saft C, Magnet MK, Sword A, Rembratt A, Tedroff J; MermaiHD study investigators. Pridopidine for the treatment of motor function in patients with Huntington's disease (MermaiHD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Dec;10(12):1049-57. doi: 10.1016/S1474-4422(11)70233-2. Epub 2011 Nov 7.

    PubMed 22071279

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ACR16 in people with Huntington's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 31 sites in 8 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 11 inclusion and 21 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 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United Kingdom, Germany, France, Spain, Austria and 3 more countries. 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. Some participants in this study may receive a placebo. 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 29 Aug 2023). 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?

Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the Unified Huntington's Disease Rating Scale [UHDRS] Motor Assessments) at Week 26 (time frame: Baseline, Week 26). 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 NCT00665223, which also lists 2 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 29 Aug 2023.

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