NCT01444690

Brief Summary

The purpose of this study is to assess the efficacy and tolerability of orally administered dimiracetam for 10 weeks to AIDS patients under treatment with antiretroviral agents presenting a disease and /or treatment related neuropathic pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
244

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 3, 2011

Status Verified

September 1, 2011

Enrollment Period

1 year

First QC Date

September 29, 2011

Last Update Submit

September 30, 2011

Conditions

Acquired Immunodeficiency Syndrome

Keywords

Antiretroviral therapyAcquired Immunodeficiency Syndrome/complications*Anti-HIV Agents/adverse effects

Outcome Measures

Primary Outcomes (2)

  • Pain intensity measured on 100 mm VAS

    Change from baseline in pain intensity as measured on VAS

    71 days

  • Pain intensity as measured with Total Symptom Score (TSS)

    Change from baseline as measured with TSS

    71 days

Secondary Outcomes (4)

  • Adverse events

    78 days

  • Number needed to treat

    71 days

  • CD4+ cell count

    78 days

  • HIV viral load

    78 days

Study Arms (2)

Active

EXPERIMENTAL

Dimiracetam 400 mg capsules

Drug: Dimiracetam

Pseudo-placebo

PLACEBO COMPARATOR

Dimiracetam 25 mg capsules

Drug: Dimiracetam 25 mg

Interventions

DimiracetamDRUG

Capsules for oral administration twice daily

Active
Dimiracetam 25 mgDRUG

Inactive dose level in capsules administered orally twice daily

Pseudo-placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male and female patients aged 18-75 years inclusive;
  • females of child-bearing potential only if agreeing prior to screening to use a medically accepted method of contraception, i.e., oral or injectable hormonal contraceptive with a second method of birth control, medically prescribed intrauterine device (IUD), or double barrier method (condom in combination with spermicidal). Females, who are not currently sexually active, only if agreeing and consenting to use one of the above-mentioned methods in case they become sexually active while participating in the study;
  • females of not child-bearing potential only if permanently sterilised or if in post-menopausal status, only if they have been in this status for at least 2 years; females of not child-bearing potential are exempted from the requirement for use of contraception;
  • HIV-positive patients treated with ARTs;
  • CD4+ cell count \> 200/μL at the screening;
  • patients affected by current neuropathic pain likely to be ART treatment related. The diagnosis shall be made by a physician and based on history, clinical and/or laboratory findings in accordance with the taxonomy of the diagnostic criteria documented in the International Association for the Study of Pain (IASP) Classification of Chronic Pain;
  • naïve neuropathic patients or non-responders (residual pain ≥40 mm on the VAS) to standard neuropathy treatments. Drugs for neuropathic pain (NP) must be stopped at screening visit;
  • pain intensity ≥40 mm on the VAS at screening;
  • pain intensity ≥40 mm on the VAS as the mean of the values collected on the last 4 days prior to the start of treatment (baseline VAS);
  • life expectancy of at least 6 months;
  • ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
  • ability to co-operate with the Investigator or designee and to comply with the requirements of the entire study

You may not qualify if:

  • pregnant or lactating females;
  • presence of active AIDS-defining opportunistic infections (with the exception of tuberculosis) or malignant neoplasia requiring treatment at study entry or Kaposi's sarcoma or another malignant neoplasia likely to require chemotherapy;
  • any clinically significant underlying disease, according to the Investigator's clinical judgment;
  • history of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment);
  • any current DSM-IV Axis I diagnosis including dementia, depression, psychosis, anxiety disorders, mental retardation;
  • participation in the evaluation of any investigational drug within 3 months prior to screening (6 months if for treatment of neuropathic pain)
  • treatment with neurostimulating devices such as spinal cord stimulation (SCS), acupuncture, homeopathic remedies for pain or any kind of surgical treatment or blockade for the pain in the 4 weeks prior to screening;
  • treatment with any drug for neuropathic pain (NP) after the screening visit;
  • requirement of more than 2 transfusions / month to achieve haemoglobin level \> 8 g/dL;
  • history of alcohol abuse (no more than 4 drinks in a day and 14 drinks in a week for men or 3 drinks per day and 7 drinks in a week for women as defined according to both NIAAA and USDA dietary guidelines) or drug abuse during the last 3 mo prior to screening;
  • Less than 1 VAS assessment per day for each of the last 4 days.
  • history of allergic response to neuropathic treatments or history of anaphylaxis or allergic reactions to drugs in general;
  • any abnormality that the Investigator deems to be clinically relevant, either on medical history, physical examination, ECG or in diagnostic laboratory test;
  • subjects likely to be non-compliant or uncooperative during the study according to the Investigator or designee's judgement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurotune AG

Lugano, Switzerland

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dimiracetam

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Rugerro Fariello, MD

    Neurotune AG

    STUDY DIRECTOR

Central Study Contacts

Rugerro Fariello, MD

CONTACT

+41-91-6056542ruggero.fariello@neurotune.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 3, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 3, 2011

Record last verified: 2011-09

Locations

CH(1)