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Trial record 2 of 4 for:    allod-2

Twice Daily Oral ALLOD-2 vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4)

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ClinicalTrials.gov Identifier: NCT03201393
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Allodynic Therapeutics, LLC

Brief Summary:

This proof-of-concept study evaluates ALLOD-2 for the treatment of chronic low back pain.

The investigational product (ALLOD-2), is a combination of two marketed drugs. Both drugs are used at much lower doses than the doses used for the approved indications.

The combination is a First-in-Class drug due to its new and unique mechanism of action.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Lumbar Radiculopathy Drug: ALLOD-2 Capsules Drug: Placebo Capsules Phase 2 Phase 3

Detailed Description:
This is a 20-week, single-site study with three study periods: a 4-week baseline period, a 12-week double-blind treatment period, and 4-week post-treatment follow-up period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single Site, Phase 2B, Randomized, Double-Blind, Study to Assess the Efficacy, Safety, and Tolerability of Twice Daily Oral ALLOD-2 vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4)
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: ALLOD-2 Capsules
Component A and Component B
Drug: ALLOD-2 Capsules
One capsule contains component A and one capsule contains component B taken together twice a day for 12 weeks.

Placebo Comparator: Placebo Capsules
Placebo for Component A and Placebo for Component B
Drug: Placebo Capsules
One capsule contains placebo for component A and one capsule contains placebo for component B taken together twice a day for 12 weeks.




Primary Outcome Measures :
  1. The change from baseline in mean 7-day, 24-hour Worst Pain Intensity (WPI). [ Time Frame: From baseline to the last 7 days of the 12-week double-blind treatment period. ]
    The mean weekly WPI score will be derived from assessments recorded by patients daily at bedtime. The WPI score is measured on the 11-point (0-10) Numeric Rating Scale (NRS), (0=no pain, 10=worst possible pain).


Secondary Outcome Measures :
  1. The change from baseline in mean 7-day, 24-hour Average Pain Intensity (API). [ Time Frame: From baseline to the last 7 days of the 12-week double-blind treatment period. ]
    The mean weekly API score will be derived from assessments recorded by patients daily at bedtime. The API score is measured on the 11-point (0-10) NRS.

  2. Proportion of patients with 50% or more reduction in 7-day, 24-hour Worst Pain Intensity (WPI). [ Time Frame: From baseline to the last 7 days of the 12-week double-blind treatment period. ]
    The mean weekly WPI score will be derived from assessments recorded by patients daily at bedtime. The WPI score is measured on the 11-point (0-10) NRS.

  3. The change from baseline in mean 7-day, 24-hour Right Now Pain Intensity (NPI). [ Time Frame: From baseline to the last 7 days of the 12-week double-blind treatment period. ]
    The mean weekly NPI score will be derived from assessments recorded by patients daily at bedtime. The NPI score is measured on the 11-point (0-10) NRS.

  4. The change from baseline in mean 7-day, 24-hour Pain-Related Interference (PRI) with day-to-day activities. [ Time Frame: From baseline to the last 7 days of the 12-week double-blind treatment period. ]
    The mean weekly PRI score will be derived from assessments recorded by patients daily at bedtime. The PRI score is measured on the 11-point (0-10) NRS.

  5. The change from baseline in mean 7-day, 24-hour pain-related sleep interference (PRSI). [ Time Frame: From baseline to the last 7 days of the 12-week double-blind treatment period. ]
    The mean weekly PRSI score will be derived from assessments recorded by patients daily at bedtime. The PRSI score is measured on the 11-point (0-10) NRS.

  6. Change from baseline in the mean number of rescue medications used. [ Time Frame: From baseline to the last 7 days of the 12-week treatment period. ]
    Rescue medications use will be derived from daily recordings by patients.

  7. Change from baseline in the mean Oswestry Disability Index (ODI). [ Time Frame: From baseline to the last 7 days of the 12-week double-blind treatment period. ]
    Patients will complete the ODI instrument during site visits (%).

  8. Change from baseline in the mean Pittsburgh Insomnia Rating Scale-20 (PIRS-20). [ Time Frame: From baseline to the last 7 days of a 12-week double-blind treatment period. ]
    Patients will complete the PIRS-20 instrument during site visits (0-60).


Other Outcome Measures:
  1. Comparison of the proportion of patients who experienced adverse events. [ Time Frame: Completion of the treatment period at 12 weeks. ]
    Defined as any untoward medical occurrences, regardless of their suspected cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is a male or female 18 years of age or older.
  2. A clinical diagnosis of nonmalignant, chronic low back pain (CLBP). LBP, as defined by Quebec Task Force in class 1 - pain without radiation and class 2 - pain with proximal radiation above the knee. CLBP is defined as being present for at least several hours a day, at least half the days in the previous 6 months, and being the principal pain condition. (In accordance with the NIH 2013 Task Force on Research Standards for Chronic Low Back Pain).
  3. The 24-hour average pain intensity (API) mean score for the baseline period is ≥ 4 and ≤ 8, [measured on the 11-point (0-10) numeric rating scale (NRS)] with each individual score ≥ 3. In addition, the Oswestry Disability Index (ODI) score during the Randomization Visit is ≥ 30% and ≤ 60%.

5. The patient agrees to refrain from taking opiate medications from Visit 1 to 7 days after the last dose of the study drug.

6. The patient agrees to limit their rescue pain medications to acetaminophen 2000 mg per day for the duration of the study.

7. The patient is willing and able to discontinue use of non-pharmacological pain management modalities (e.g. TENS, physical therapy, chiropractic manipulations, biofeedback, and acupuncture) for the duration of the study.

8. The patient has been taking a stable dose of a medication with pain prevention potential for at least 6 weeks prior to the screening visit and agrees to not start, stop, or change the dose of any medication with pain prevention potential during the study period. (E.g., tricyclic antidepressants, anticonvulsants, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), herbal preparations (e.g. feverfew or St. John's wort)). Botulinum toxin injections and steroid injections to the spine must be discontinued six months prior to Visit 1.

9. The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA.

10. The patient agrees not to undergo any elective surgery, including spine surgery or injections to the spine (e.g. botulinum toxin, steroid, etc.) for the duration of the study.

11. The Female patient who is premenopausal or postmenopausal less than 1 year, or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative serum pregnancy test, be non-lactating, and commit to using adequate and reliable contraception throughout the study (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). Male patients must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after the study.

Exclusion Criteria:

  1. The patient has any condition consistent with Quebec Task Force Classification 3-11.
  2. The patient has another painful condition that may require analgesic medications, occurring regularly or intermittently (e.g. menstrual pain, carpal tunnel syndrome, arthritis, tendinitis, etc.).

The patient has concomitant migraine unless he/she treats migraine attacks only with ergotamine or triptans.

4. Regular use of the following medications for any reason: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), antipsychotic drugs, monoamine oxidase inhibitors, muscle relaxants, blood thinning medications (e.g., warfarin or heparin), or cannabinoids. Low-dose aspirin for cardiovascular disease prophylaxis is permitted.

5. Diagnosis of any concurrent medical or psychiatric condition; this includes, chronic unstable debilitating diseases such as Parkinson's disease, multiple sclerosis, cancer, significant renal impairment, significant hepatic impairment, etc.

6. The patient has a history or diagnosis of moderate-to-severe hepatic or renal impairment (>2 × the upper limit of normal [ULN] for alanine transaminase or aspartate transaminase. ≥1.5 × ULN for Alkaline Phosphatase, bilirubin, BUN, or Creatinine). (Patients with elevated bilirubin level due to Gilbert's syndrome are allowed).

7. The patient has a history of the previous 5 years of abuse of any drug, prescription, illicit, or alcohol.

8. The Female patient is pregnant or breastfeeding. The Male patient is not practicing 2 different methods of birth control with their partner during the study, and for 28 days after the investigational drug last dose or will not remain abstinent during the study, and for 28 days after the last dose.

9. The patient has known-hypersensitivity to components of the investigational drug.

10. Participation in another study with an investigational drug within 30 days before Visit 1 or during the study.

11. The patient is in the opinion of the investigator, unsuitable to participate in this study for any other reason.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201393


Locations
United States, Florida
Annette C. Toledano, M.D.
North Miami, Florida, United States, 33181
Sponsors and Collaborators
Allodynic Therapeutics, LLC
Investigators
Principal Investigator: Annette Toledano, M.D. Allodynic Therapeutics, LLC

Responsible Party: Allodynic Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT03201393     History of Changes
Other Study ID Numbers: ANODYNE-4
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Allodynic Therapeutics, LLC:
Back pain
Neuropathic Pain
Radiculopathy
Allodynia

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Radiculopathy
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases